shockwave coronary lithoplasty® study (disrupt cad ii)

Conditions: Coronary Artery Disease

Summary: the objective of this post market study is to examine the safety and performance of the shockwave coronary intravascular lithotripsy system for the treatment of narrowed coronary arteries before the doctor places a stent.

the study will be conducted at 15 sites in europe and up to 120 participants will be followed for 30 days post procedure. patients ≥18 years of age scheduled for stent procedure with evidence of significant calcified stenosis of left main, or left anterior descending, right coronary artery or left circumflex will be eligible to enroll in the study. the primary endpoint of the study will evaluate major adverse cardiac events post procedure including 1) cardiac related death, 2) heart attack, and 3) intervention to treat the coronary artery that was previously treated at the procedure visit.

Eligibility criteria:
inclusion criteria: 1. patient is ≥ 18 years of age 2. troponin must be less than or equal to the upper limit of lab normal value within 24 hours prior to the procedure or if troponin is elevated, concomitant ck must be normal 3. the target vessel must have a timi flow 3 at baseline 4. patients with significant (≥ 50% diameter stenosis) native coronary artery disease including stable or unstable angina and silent ischemia, suitable for pci 5. ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel, prasugrel, or ticagrelor) for 1 year and single antiplatelet therapy for life 6. single lesion stenosis of protected lmca, or lad, rca or lcx artery ≥50% in a reference vessel of 2.5 mm - 4.0 mm diameter and ≤ 32 mm length 7. presence of calcification within the lesion on both sides of the vessel as assessed by angiography 8. planned treatment of single lesion in one vessel 9. ability to pass a 0.014" guide wire across the lesion 10. patient, or authorized representative, signs a written informed consent form to participate in the study, prior to any study-mandated procedures 11. patient is able and willing to comply with all assessments in the study exclusion criteria: 1. concomitant use of atherectomy, specialty balloon, or investigational coronary devices 2. prior pci procedure within the last 30 days of the index procedure 3. patient has planned cardiovascular interventions within 30 days post index procedure 4. second lesion with ≥50% stenosis in the same target vessel 5. left ventricular ejection fraction \< 40% 6. patient refusing or not a candidate for emergency coronary artery bypass grafting (cabg) surgery 7. uncontrolled severe hypertension (systolic bp \>180 mm hg or diastolic bp \>110 mm hg) 8. severe renal failure with serum creatinine \>2.5 mg/dl, unless on chronic dialysis 9. untreated pre-procedural hemoglobin \<10 g/dl 10. coagulopathy manifested by platelet count \ 1.7 (inr is only required in patients who have taken warfarin within 2 weeks of enrollment) 11. patients in cardiogenic shock 12. acute myocardial infarction (mi) within the past one (1) month, and/or signs of active myocardial ischemia at the time of enrollment including elevated troponin-i or t (with concomitant elevation of ck), ischemic ecg changes or chest pain 13. history of a stroke or transient ischemic attack (tia) within 3 months 14. nyha class iii or iv heart failure 15. active peptic ulcer or upper gastrointestinal (gi) bleeding within 6 months 16. patients with a life expectancy of less than 1 year 17. target vessel \< 2.4 mm in diameter 18. target lesion \> 32 mm in length 19. chronic total occlusion (cto) 20. previous stent procedure within 5 mm of target lesion 21. angiographic evidence of a target lesion severe dissection prior to coronary lithoplasty treatment 22. unprotected left main diameter stenosis ≥ 50% 23. visible thrombus (by angiography) at target lesion site 24. target lesion is located in a native vessel distal to anastomosis with a saphenous vein graft or lima/rima bypass 25. patient has active systemic infection 26. patient has connective tissue disease (e.g., marfan's syndrome) 27. patient has a hypercoagulable disorder 28. uncontrolled insulin dependent diabetes 29. patient has allergy to imaging contrast media for which they cannot be pre-medicated 30. evidence of aneurysm in target vessel 31. patient is pregnant or nursing